Kornimate/medical-research-clean huggingface dataset:
low level laser therapy for radiation induced dermatitis in h & n squamous cell carcinoma

Conditions: Radiation Dermatitis

Summary: this study will assess the efficacy of lllt to mitigate and ameliorate the acneiform-rash, radiation dermatitis, and pain, while assessing its impact on patient reported quality of life.

this single-arm phase i/ii study establishes the safety and efficacy of low level laser therapy (lllt) in order to mitigate radiation-induced dermatitis in patients underoing radiation therapy for head and neck squamous cell carcinoma (hnscc). additional objectives include assessment of patient-reported quality of life data, pain parameters and dermatologic quality of life responses. the target population is patients with histologically proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx who are candidates for either definitive or adjuvant therapy consisting of a chemotherapy regimen and concurrent radiation therapy. patients are required to have a favorable performance status (kps greater than or equal to 70), have had no prior head and neck radiotherapy and be at least 18 years of age and able to provide consent. while receiving radiotherapy and a concurrent systemic regimen, patients will receive lllt using a 69 diode probe with dual 660 nm and 850 nm wavelengths to at least nine treatment sites in the head and neck region for a duration of 60 seconds to each site. lllt will be given three times in a week prior to, daily during the first week of, and at least twice weekly thereafter during radiotherapy. information collected includes toxicity scoring and quality of life surveys. a retrospective matched-pair design will be used to assess the rate of grade iii complications compared to patients treated previously without lllt support, with an anticipated 20% reduction in the risk of grade iii dermatitis.

Eligibility criteria:
inclusion criteria: * male or female patients ≥ 18 years of age * karnofsky performance status \> 70 * histologic proof of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx * no prior radiotherapy to the head and neck region. * no previous systemic chemotherapy or targeted therapy * must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts. * patients using standard therapies for cetuximab-induced acne-form rash will be included. exclusion criteria: * evidence of distant metastasis on upright chest x-ray (cxr), computed tomography (ct) or other staging studies * any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the investigator * concurrent serious infection * continued use of niacin
evaluating an internet-based program for anxious adolescents

Conditions: Anxiety

Summary: anxiety is a common mental health problem for canadian adolescents. anxiety that is diagnosed as a disorder and serious enough to require treatment affects up to 10% of all adolescents by the age of 16. the median age of onset is 11 years, making these disorders some of the earliest to develop. anxiety disorders can have serious negative effects on a young person's personal relationships, school performance, and family life. these disorders may not be discovered by adolescents, parents and health care providers. even if anxiety disorders are discovered, adolescents may not get the right therapy. anxious adolescents can become sick if their anxiety is not treated properly. the investigators will carry out research to test breathe, an internet-based treatment for adolescents with anxiety problems. adolescents can use this treatment from home via the computer. breathe will include information materials and personalized homework assignments to help anxious adolescents learn ways to manage anxiety. more information can be found and www.thebreathestudy.com

this study is a randomized controlled trial (rct) with two groups, an internet-delivered cognitive behavioural therapy (cbt) experimental group (breathe) and a resource webpage (control group; considered treatment as usual for youth waiting for services). the investigators will evaluate several methodological processes and outcomes through the following objectives: 1. to determine the effectiveness of a self-guided internet-based cbt program with limited telephone and email support in reducing anxiety symptoms among adolescents with mild-to-moderate anxiety as compared to a usual self-help intervention, a resource-based webpage. 2. to explore mediators and moderators of the internet-based cbt program. 3. to determine the effectiveness of a self-guided internet-based cbt program in improving quality of life as compared to a usual self-help intervention. 4. to determine adherence to a self-guided internet-based cbt program. 5. to determine the cost-effectiveness of the internet-based cbt program.

Eligibility criteria:
inclusion criteria: * score of ≥25 on the screen for child anxiety related disorders (scared) * ability to read and write english * regular access to a telephone and a computer system with high speed internet service * ability to use the computer to interact with web material exclusion criteria: * positive screen on the ask suicide-screening questionnaire (asq) * positive screen on the schizophrenia test and early psychosis indicator (stepi; modified version) * score of ≥3 on the alcohol use disorders identification test consumption subscale (audit-c) * residence outside of canada
comparing the efficacy, safety, and tolerability of rabeprazole er 50 mg with placebo in subjects with symptomatic gastroesophageal reflux disease (sgerd)

Conditions: Symptomatic Gastroesophageal Reflux Disease (sGERD)

Summary: the purpose of this study is to compare the efficacy, safety and tolerability of rabeprazole extended release (er) 50 mg with placebo in subjects with symptomatic gastroesophageal reflux disease (sgerd).


Eligibility criteria:
key inclusion criteria: male or female, ages 18 through 75 years will be included in the study. females should be either of nonchildbearing potential or of childbearing potential. females of childbearing potential must have negative serum and urine pregnancy tests prior to randomization. female subjects of childbearing potential must agree to use medically acceptable methods of contraception starting at visit 1 and throughout the entire study period and for 1 month after the last dose of study drug. women using hormonal contraceptives must also be using an additional approved method of contraception starting at visit 1 and throughout the entire study period and for 1 month after the last dose of study drug. pregnant or lactating females are excluded. subjects must have a history of heartburn, identified as their main complaint, for 6 months or longer.subjects must have documentation of a minimum of 5 moderate to severe heartburn episodes, 3 of which occur during the daytime and 1 of which occurs during the nighttime, during the last 7 days before randomization. subjects must be able to read, write, and understand the language of the symptom dairy. key exclusion criteria: subjects will be excluded from the study if they are found to have erosive esophagitis during esophagogastroduodenoscopy (egd) at screening, current or a history of esophageal motility disorders, current or a history of barrett's esophagus, current esophageal strictures or esophagitis (known or suspected to be due to etiology other than gerd such as infection or medications), current or a history of zollinger-ellison syndrome and acid hypersecretory conditions, or current gastric or duodenal ulcer. subjects will be excluded if they are found to have current or a history of cancer, with the exception of fully excised skin basal cell carcinoma, inflammatory bowel disease, a history of esophageal, gastric and duodenal surgery, except simple closure of a perforated ulcer. subjects will be excluded who require daily use of nonsteroidal anti-inflammatory drugs (nsaids), oral steroids (\>=20 mg/day prednisone or equivalent), or aspirin (\>325 mg/day). female subjects will be excluded who are pregnant, lactating, or have a positive b-human gonadotropin test at screening/baseline. subjects will be excluded who are known to be human immunodeficiency virus (hiv) positive, have participated in another investigational drug study within 30 days prior to screening or are expected to receive an investigational drug during this trial. subjects who are unwilling to provide informed consent will be excluded.

Keywords: gastroesophageal reflux disease gerd
cognitive and behavioral outcomes of school-aged children who were born preterm

Conditions: Very Low Birth Weight Infants

Summary: this study evaluates the cognitive and behavioral outcomes including image findings of school-aged children who were born preterm compared with who were born term gestational age.

there are lots of studies published that school-aged children who were born preterm has some behavioral problems in school and they also have poor academical achievement.

Eligibility criteria:
inclusion criteria: * children former preterm infants \< 32 weeks of gestation or 1,500gm of birth weight * children former normal term infants exclusion criteria: * major congenital anomaly * neuromuscular disease * chromosomal anomaly
treatment with autologous skeletal myoblasts

Conditions: Old Myocardial Infarction

Summary: the purpose of this study is to determine the benefit of autologous skeletal myoblast injection in patients with old myocardial infarction and ventricular dysfunction versus conventional revascularisation therapy.

ischaemic heart disease is one of the main causes of mortality and morbidity. in particular, myocardial infarction (mi) is of special significance, as the heart muscle cannot regenerate so a region's necrosis leads to the formation of a fibrous scar. depending on the area affected by the scar, infarction can lead to a progressive and irreversible decline in cardiac function, giving way to heart failure (hf) syndrome. the molecular basis of congestive heart failure is the absence of cardiac stem cells capable of regenerating cardiac muscle. in the skeletal muscle, there are cells located beneath the basal membrane with are capable of regenerating muscle fibres; they are known as myoblasts. there are several studies with autologous myoblasts, either by direct administration during surgery or percutaneously, which could distinguish between the effect of revascularisation surgery and that of the myoblast injection. the objective of this study is compare improvement in global and regional cardiac function in patients with old mi obtained by aortocoronary bypass surgery with intracardiac administration of autologous skeletal myoblasts versus standard aortocoronary bypass surgery treatment.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of coronary disease obtained by coronary angiography who require conventional aortocoronary bypass surgery. * history of myocardial infarction with evidence of regional akinesis (or dyskinesia) for more than 4 weeks and less than 10 years. * ejection fraction from 25% to 45%. * evidence of no regional viability by dobutamine echocardiography. * aged from 30-80 years old. * negative serology to hiv, hbv and hcv. * patients without organ dysfunction. * negative pregnancy test (women of childbearing age). * informed consent granted. exclusion criteria: * history of myocardial infarction in the 4 weeks prior to the inclusion in the study. * prior history of tachycardia or ventricular fibrillation (except in patients with dai device). * history of cancer (except basocellular carcinoma) or prior treatment with chemotherapy. * the patient should not suffer from any concomitant severe and/or uncontrolled medical condition. * patients who, due to their geographical, psychiatric or social status, have difficulties in meeting the conditions established in the protocol. * pregnant or beast feeding women.

Keywords: intra-lesion injection of autologous myoblasts
the impact of spc on advanced breast cancer patients

Conditions: Breast Cancer; Palliative Care; Quality of Life; Cancer, Breast

Summary: the aim of this prospective, observational study is the evaluation of the effectiveness of a 14-day specialist palliative care therapy in participants with advanced breast cancer carried out in a stationary palliative care unit in poland. the length of the entire study will be 36 months.


Eligibility criteria:
inclusion criteria: the patient's conscious consent for examination and the ability to fill in the form by the patient herself. - exclusion criteria: * patients with cognitive disturbances disabling credible answers in the questionnaire, deceased patients or those discharged from the ward before 14 days of hospitalisation.

Keywords: breast cancer palliative care life quality performance status esas
pressure opening with electrical impedance tomography

Conditions: Acute Respiratory Distress Syndrome; Acute Lung Injury

Summary: acute lung injury and ards (acute respiratory distress syndrome) are characterized by lung inhomogeneity, leading to a different distribution of the tidal volume (and pressure) within the lung. the quasi-static pv curve is a useful bedside tool to set mechanical ventilation, but it reflects a global behaviour of the lung. the electrical impedance tomography (eit) is a non-invasive and radiation-free tool, monitoring dynamic changes in gas distribution. images from eit can be divided in several regions of interest, allowing to measure regional changes in compliance. the regional derived-eit pv curve could provide valuable information on airway closure and aop (airway opening pressure). recent studies suggest that aop measured by the ventilator seems to correspond to the aop of the lowest injured lung. the investigators will perform one pressure-volume (pv) curve with a low-flow insufflation of 5 l/min starting from 0 cmh2o to a maximal airway pressure corresponding to the plateau pressure. during the low-flow insufflation, both ventilator and eit-derived pv curves will be recorded. all pv curves will be analysed offline by the investigator to detect complete and regional airway closures, and measure aops.


Eligibility criteria:
inclusion criteria: * adult patients (≥18 years old). * patients with pao2/fio2 ratio \<300 mmhg. * volume- or pressure-controlled ventilation. * sedated, with or without infusion of neuromuscular blockage. * patients in supine position exclusion criteria: * pneumothorax and bronchopleural fistula. * severe hemodynamic instability (\>30 % increase in vasopressors in the last 6 hours or norepinephrine \> 0.5 µg/kg/min). * pao2/fio2 ratio \< 80 mmhg. * severe or very severe chronic obstructive pulmonary disease (copd) according to the gold criteria (stage iii: fev1 30-50% predicted; stage iv: fev1 \< 30 % predicted). * known or highly suspected elevated intracranial pressure (\>18 mmhg). * impossibility to correctly position the eit belt (e.g., burns chest drainage, etc.). * contraindications to eit (e.g., implantable cardiac defibrillator, pacemaker, instable spinal lesions, etc.). * clinical judgement of the attending physician. * pregnant or breastfeeding woman * patient under guardianship, curators or safeguard of justice

Keywords: airway closure airway opening pressure acute respiratory distress syndrome acute lung injury
rad 1801: pilot study of intra-urethral radiotransponder beacon guided focal prostate stereotactic body radiotherapy

Conditions: Prostate Cancer

Summary: this study offers focal therapy for prostate cancer by using an intra-urethral radiotransponder temporarily placed during radiotherapy. the study aims to improve the risk-benefit ratio of therapy for early prostate cancer and potentially lessen symptom burden over time.

this study offers focal stereotactic body radiotherapy for prostate cancer by using an intra-urethral radiotransponder placed temporarily during each of the 5 radiotherapy treatments. the study aims to improve the risk-benefit ratio of therapy for early prostate cancer and potentially lessen symptom burden over time while also accessing early efficacy, late toxicity, and overall quality of life post-treatment. patients will be followed for 24 months (2 years) with follow-up appointments at 3, 6, 9, 12, 18, and 24 months.

Eligibility criteria:
inclusion criteria: * all patients must have histologically confirmed adenocarcinoma of the prostate, with biopsies obtained within 12 months of registration * gleason score 3+3 or 3+4 * psa \<10 ng/ml within 3 months of enrollment * clinical stage t1a-t2a by digital rectal exam * up to 2 intraprostatic nodules visible on mri, with combined volume \<50% of the total prostate volume * karnofsky performance status (kps) \>70%. * life expectancy \>10 years * age ≥ 19 years * subjects given written informed consent exclusion criteria: * \>2 mri defined nodules representing prostate cancer * total volume of mri nodules exceeding 50% of total prostate volume * positive biopsy core in sextant region without mri defined nodule (i.e. biopsy proven mri occult prostate cancer) * american urological association (aua) urinary score ≥ 18. * history of inflammatory bowel disease. * prior pelvic surgery * prior treatment for prostate cancer * patients using immunosuppressive medications or other medications that may increase radiation toxicity such as methotrexate, sirolimus, tacrolimus, or colchicine that are unable to discontinue these medications during sbrt course. use of corticosteroids is not considered an exclusion criteria. * platelet count \< 70,000/µl * patients unable to discontinue anti-platelet or anti-coagulant medicine such as clopidogrel, dabigatran, warfarin, or low molecular weight heparin. use of aspirin is not an exclusion criteria. * contraindication to mri such as implanted devices. * metallic pelvic implants resulting in imaging artifact within the prostate on mri or ct

Keywords: focal therapy prostate cancer sbrt intra-urethral transponder
closing the loop in young children with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the incidence of type 1 diabetes (t1d) is increasing worldwide with evidence of most rapid increase in preschool children. intensive control of blood glucose levels, although essential to protect against onset and progression of diabetes-related complications, faces unique challenges in toddlers and preschool children. a closed-loop system can enhance accuracy of insulin delivery and help people with t1d attain a tight glucose control avoiding the risk of hypoglycaemia. the main components of the system are a continuous glucose monitor (cgm), an insulin pump and a computer-based 'model predictive algorithm', which calculates the amount of insulin to be given by the insulin pump according to the cgm values. in the studies performed thus far the efficacy and safety of closed-loop glucose control were evaluated in children and adolescents aged 6 to 18 years. the results showed that closed-loop improved control of blood glucose and prevented nocturnal hypoglycaemia, as compared to the conventional insulin pump therapy. the objective of the current study is to extend the evaluation of closed-loop further to younger children aged 2 to 6 years, who may gain a great benefit from this novel therapy. the present study adopts an open-label, randomised, 2 period cross-over design whereby closed-loop insulin therapy using diluted insulin (20iu/ml)will be compared with closed-loop with standard insulin (100iu/ml)in 12 young children with t1d. participants aged 2 to 6 years will be randomised for two overnight studies in a clinical research facility, during which glucose levels will be controlled by either the computer-based closed-loop algorithm using diluted insulin or by closed-loop with standard insulin. on both occasions, participants will receive a self-selected evening meal and closed-loop will run from 17:00 until 08:00am the following day. the study will take place at the wellcome trust clinical research facility, cambridge with participants recruited from paediatric diabetes clinics in england.


Eligibility criteria:
inclusion criteria: * the subject is between 2 and 6 years of age (inclusive) * the subject has had type 1 diabetes, as defined by who criteria for at least 6 months * the subject will be an insulin pump user and carers will have a good knowledge of insulin dose adjustment * hba1c below 12 % (108mmol/mol) exclusion criteria: * non-type 1 diabetes mellitus including those secondary to chronic disease * any other physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results * current treatment with drugs known to interfere with glucose metabolism such as systemic corticosteroids * known or suspected allergy against insulin
comparison of acute toxicity and cost between whole breast irradiation with sequential boost and simultaneous integrated boost after breast conserving surgery.

Conditions: Radiotherapy After Breast Conserving Surgery

Summary: whole breast irradiation (wbi) after breast conserving surgery for early-stage breast cancer halves the recurrence risk and reduces the breast cancer death by about one sixth. a sequential boost (seqb) dose to the tumour bed further improves local control, but also increases the risk of late skin toxicity and cosmetic changes. at ghent university hospital wbi is prescribed in 15 fractions of 2.67 gy according to the start-b hypofractionation scheme. a sequential boost is typically given in 4 to 8 extra fractions which prolongs the overall treatment time. the boost dose can also be delivered within the 15 fractions of wbi, the so-called simultaneous integrated boost (sib). sib shortens the overall treatment time which is convenient for the patient and the radiotherapy department. in this study we wish to test the hypothesis of acceptable skin toxicity and reduced cost with sib using hypofractionated prone intensity modulation radiotherapy imrt with topographical dose painting, a technique recently developed in our group. patients are randomized between seqb and sib.


Eligibility criteria:
inclusion criteria: female patients and breast conserving surgery and multidisciplinary decision of adjuvant wbi with a boost to the tumor bed and age ≥ 18 years and informed consent obtained, signed and dated before specific protocol procedures exclusion criteria * mastectomy * need for lymph node irradiation * no boost * bilateral breast irradiation * patient not able to reach or maintain the prone position * pregnant or breastfeeding * mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study * patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study

Keywords: radiotherapy